An Effectiveness and Safety Study of Cyclobenzaprine HCl Alone or in Combination With Ibuprofen for Acute Back or Neck Muscle Pain With Muscle Spasm
Flexeril� (Cyclobenzaprine Hydrochloride) Community Based Study - An Evaluation of Cyclobenzaprine HCl Monotherapy and in Combination With Ibuprofen for Acute Back or Neck Muscle Pain With Muscle Spasm
1 other identifier
interventional
1,000
0 countries
N/A
Brief Summary
The purpose of this study is to evaluate the effectiveness and safety of cyclobenzaprine HCl 5 mg (muscle spasm medication) taken three times a day, alone or in combination with ibuprofen 400 mg or 800 mg (pain relief medication) taken three times a day, for the treatment of back or neck muscle pain with muscle spasm.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 pain
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Completion
Last participant's last visit for all outcomes
July 1, 2004
CompletedFirst Submitted
Initial submission to the registry
October 28, 2005
CompletedFirst Posted
Study publicly available on registry
October 31, 2005
CompletedFebruary 18, 2011
February 1, 2011
October 28, 2005
February 17, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Subject-rated global impression of change from baseline, after seven days of treatment
Secondary Outcomes (1)
Subject global impression of change after 3 days; Proportion of responders after 3 and 7 days, Change from baseline in subject-rated pain intensity, muscle spasm intensity, functional ability, and medication helpfulness after 3 and 7 days.
Interventions
Eligibility Criteria
You may qualify if:
- Experiencing neck or back pain for no more than 14 days
- Physician rating of the muscle spasm of the neck or back region as mild, moderate or severe
- Ability to discontinue all muscle relaxants, NSAIDs (anti-inflammatory drugs) and pain relievers, other than the study medications during the 7-day treatment period. (Cardioprotective doses of aspirin (\<= 325 mg / day) may be taken.)
You may not qualify if:
- History of physician-diagnosed musculoskeletal neck or back muscle spasms within 12 months prior to the study
- neck or back pain radiating into the arms or legs
- history of serious medical conditions
- taken a narcotic or muscle relaxant within 12 hours of the baseline physician visit
- allergies to aspirin, NSAIDs or cyclobenzaprine HCl.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Childers MK, Borenstein D, Brown RL, Gershon S, Hale ME, Petri M, Wan GJ, Laudadio C, Harrison DD. Low-dose cyclobenzaprine versus combination therapy with ibuprofen for acute neck or back pain with muscle spasm: a randomized trial. Curr Med Res Opin. 2005 Sep;21(9):1485-93. doi: 10.1185/030079905X61938.
PMID: 16197668RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
McNeil Consumer & Specialty Pharmaceuticals, a Division of Mc Neil-PPC, Inc. Clinical Trial
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 28, 2005
First Posted
October 31, 2005
Study Completion
July 1, 2004
Last Updated
February 18, 2011
Record last verified: 2011-02